Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Behaviors and Mental Disorders

Nervous System Diseases

Rare Diseases

Lymphoma

Lymphoma, B-Cell

Aggression

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Dementia

Aberrant Motor Behavior in Dementia

Behavioral Symptoms

Lymphosarcoma

B-cell Lymphoma

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Muromonab-CD3

Odronextamab and REGN5837 will be administered by IV infusion using a step-up dosing schedule.

Odronextamab will be administered by IV infusion

Odronextamab

REGN5837 will be administered by IV infusion

REGN5837

Clinical Trials Administrator

Clinical Trial Management

The study is researching an experimental drug called REGN5837 in combination with another experimental drug, odronextamab. The aim of the study is to see how safe and tolerable the study drugs are, and to define the recommended dose for phase 2 for the combination.

The study is focused on patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (B-NHLs).

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drugs
* How much study drug is in your blood at different times
* Whether the body makes antibodies against the study drugs (that could make the drugs less effective or could lead to side effects)
* To find out how well the study drugs work against relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (B-NHLs)

A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Participants With Aggressive B-cell Non-Hodgkin Lymphomas

A Phase 1 Study to Assess Safety and Tolerability of REGN5837, an Anti-CD22 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Odronextamab, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With Aggressive B-Cell Non-Hodgkin Lymphomas (ATHENA-1)

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

A DLT is defined as any non-haematologic and haematologic toxicity, as defined in the protocol, unless the event is clearly attributable to the underlying disease or to an extraneous cause (including concomitant medications).

Treatment-emergent adverse events (TEAEs) are defined as those AEs that newly occurred or worsened during the on-treatment period and any treatment-related serious adverse events (SAEs) that occurred during the post-treatment period.

An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate.

The ORR is defined as the proportion of patients who achieve a best overall response CR or PR during or following study treatment according to the Lugano Classification based on local investigator review.

The CR rate is defined as the proportion of patients who achieve a best overall response CR during or following study treatment according to the Lugano Classification based on local investigator review.

PFS is defined as the time from the start of study treatment until the first date of progressive disease, or death due to any cause, whichever occurs first, based on local investigator review.

OS is measured from the start of study treatment until death due to any cause.

DOR is defined for responders (patients with a best overall response of CR or PR). It is the time from the date of the first documented CR or PR until the date of the first date of progressive disease, or death due to any cause, whichever occurs first, based on local investigator review.

Regeneron Pharmaceuticals

Symptoms and General Pathology

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Follicular

Lymphoma, Large B-Cell, Diffuse

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Follicular Lymphoma

Diffuse Large B-Cell Lymphoma

Participants with r/r DLBCL who were treated with at least 2 prior systemic therapies in the real-world setting

No study treatment will be administered on this study.

Non-Interventional

Primary Objective:

To evaluate objective response rate (ORR) in adult patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL) who receive systemic treatment after at least 2 prior systemic therapies in the real-world setting according to Lugano classification of malignant lymphoma (Cheson, 2014) and as assessed by independent central review

Secondary Objectives:

To evaluate the following outcomes in adult patients with r/r DLBCL who are treated with currently available therapies in the real-world setting:

1. ORR according to Lugano classification and as assessed by treating physician evaluation
2. Complete Response (CR) rate according to Lugano classification and as assessed by:

   * Independent central review, and
   * Treating physician evaluation
3. Progression Free Survival (PFS) according to Lugano classification and as assessed by:

   * Independent central review, and
   * Treating physician evaluation
4. Overall Survival (OS)
5. Duration of response (DOR) according to Lugano classification and as assessed by

   * Independent central review and
   * Treating physician evaluation
6. Disease control rate (DCR) according to Lugano classification and as assessed by:

   * Independent central reviewed
   * Treating physician evaluation
7. Time to next treatment (TTNT)

Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Outcomes in Patients With Relapse/Refractory Diffuse Large B-Cell Lymphoma Treated With Systemic Therapy From Real-World Experience (ORCHID)

The proportion of best overall response of complete response (CR) or partial response (PR).

The proportion of patients with a CR after initiation of the selected line of therapy (LoT).

The time from the start date of the selected LoT until the first date of progressive disease (PD) or death due to any cause, whichever occurs first.

The time from the start date of the selected LoT until death due to any cause.

The time from the date of the first documented CR or PR until the first date of PD or death due to any cause, whichever occurs first.

The proportion of patients who achieve a best overall response of CR, PR, or stable disease (SD).

The time from the start date of the selected LoT to the start of a new antineoplastic treatment line.

Antibodies, Bispecific

Other B-cell non-Hodgkin lymphoma cohort (excluding FL Grade 1-3a, DLBCL, MCL, MZL, Waldenström macroglobulinemia \[WM\]); Patients with a current diagnosis of mixed histology of B-NHL with an aggressive component (such as concurrent FL and DLBCL) will be allowed

Administered by intravenous (IV) infusion

Primary objective is to assess the anti-tumor activity of single agent odronextamab as measured by the objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review in each of the following B-cell non-Hodgkin lymphoma (B-NHL) subgroups:

* In patients with follicular lymphoma (FL) grade 1-3a \*1,2
* In patients with diffuse large B-cell lymphoma (DLBCL) \*1,2
* In patients with mantle cell lymphoma (MCL) that has relapsed after or is refractory to a BTK inhibitor. This cohort will also include patients who have relapsed or have disease refractory to prior systemic therapy, or patients who have demonstrated intolerance to BTK inhibitor therapy, and who have progressed after other systemic therapy.
* In patients with marginal zone lymphoma (MZL) \*1
* In patients with other B-NHL subtypes \*1

Secondary objectives are:

* To assess the anti-tumor activity of single agent odronextamab in each of 5 disease-specific cohorts, as measured by:
* ORR according to the Lugano Classification and as assessed by local investigator evaluation
* Complete response (CR) rate according to the Lugano Classification and as assessed local by local investigator evaluation and independent central review
* Progression-free survival (PFS)\*3
* Overall survival (OS)
* Duration of response (DOR)\*3
* Disease control rate (DCR)\*3
* To evaluate the safety and tolerability of odronextamab
* To assess the pharmacokinetics (PK) of odronextamab
* To assess the immunogenicity of odronextamab
* To assess the effect of odronextamab on patient reported outcomes, including health-related quality of life (HRQL), as measured by the validated instruments European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym), and EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L)

  * 1 that has relapsed after or is refractory to at least 2 prior lines of systemic therapy
  * 2 including an anti-CD20 antibody and an alkylating agent
  * 3 according to Lugano Classification and as assessed by independent central review and local investigator evaluation

5 cohorts The first 68 patients in the DLBCL cohort will be randomized; the remaining patients will not be randomized

A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With B-cell Non-Hodgkin Lymphoma That Have Been Previously Treated

An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

For each of the 5 disease-specific cohorts according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review.

According to the Lugano Classification, as assessed by local investigator evaluation

According to the Lugano Classification and as assessed by local investigator evaluation and independent central review

According to the Lugano Classification and as assessed by independent central review and local investigator evaluation

End of infusion \[EOI\]; Concentration at a specified time t \[Ct\])

EORTC QLQ-C30 is a self-reported, 30-item generic questionnaire developed to assess 15 domains: global health status scale, five functional scales (physical, role, emotional, cognitive, and social functioning) and nine symptom scales (fatigue, nausea, vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties).

Composed of the FACT-G plus the 15-item Lymphoma Subscale (LymS).

The EQ-5D-3L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.

Antineoplastic Agents

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Antirheumatic Agents

Carboplatin

Dexamethasone

Etoposide

Rituximab

Ifosfamide

Dexamethasone acetate

Etoposide phosphate

Isophosphamide mustard

Loncastuximab tesirine

Antineoplastic Agents, Immunological

Immunologic Factors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients will receive odronextamab given as an intravenous infusion weekly for 12 weeks, then every two weeks until nine months, and every four weeks thereafter until progression or for a maximum of two years

Patients will receive loncastuximab tesirine given as a 30-minute intravenous infusion with each cycle of modified R-ICE (maximum three cycles)

Patients will receive CAR-T cell therapy - agent TBC

Etoposide Phosphate

CAR T-cells (TBC)

Ellie Williams

Amos Burke

The Glo-BNHL trial is trying to find better medicines for children and young people with B-cell non-Hodgkin Lymphoma (B-NHL) that does not go away (refractory B-NHL) or does but comes back again (relapsed B-NHL). B-NHL is a type of cancer that develops inside or outside of lymph nodes (glands) and organs such as the liver or spleen. Examples of B-NHL are Burkitt Lymphoma and Diffuse Large B Cell Lymphoma, which may be other names used to describe this type of cancer. It is very difficult to cure relapsed or refractory B-NHL. The medicines used now are very powerful with many side effects and only cure around 30 in every 100 children treated. It is very important that investigators quickly find better medicines for these children and young people.

The Glo-BNHL trial will include three groups of children and young people, each given a new medicine (either alone or with chemotherapy). The investigators are looking to make sure the new medicines are safe and that they work to treat the cancer. If the medicine in one group does not work for a child in the trial, then they may be able to join a different group to have another new medicine.

Experts from around the world will carefully pick the medicines most likely to be helpful to be part of the trial. If one of the new medicines seems not to be working as well as hoped then the investigators will take it out of the trial as soon as possible. This will let other new medicines be added to the trial and tested. If a medicine does seem to be working well, then it will continue in the trial to make sure it really is the most useful medicine available.

Children from around the world will be invited to take part in the trial. The investigators will then check on them for at least two years after they finish the trial treatment to look for possible side effects of the new medicine.

Glo-BNHL is an adaptive prospective international multicentre platform clinical trial designed to evaluate the safety and efficacy of novel agents for the treatment of children, adolescents, and young adults with relapsed and/or refractory B-cell non-Hodgkin Lymphoma (r/r BNHL). The trial is designed to generate sufficient evidence to potentially be practice-changing in this rare cancer setting. With the trial incorporating an initial stage evaluating efficacy followed potentially by an expansion stage to provide confirmatory analysis, the trial could be considered to be phase II/III.

Novel agents will be prioritised for inclusion in the platform according to an overarching prioritisation list and a robust systematic scientific assessment, performed by the international Trial Steering Committee (TSC).

The platform consists of three parallel treatment arms, each one investigating a different novel agent in a group of patients. The platform allows the testing of a pipeline of novel agents in each treatment arm consecutively. Patients in the platform may be enrolled into any of the available treatment arms for which they are eligible. The classes of novel agents prioritised for inclusion at the initiation of the trial are:

* Treatment Arm I: Bispecific antibodies (BsAbs)
* Treatment Arm II: Antibody-drug conjugates (ADC) with standard chemotherapy
* Treatment Arm III: Chimeric antigen receptor (CAR) T-cells

The platform trial has an adaptive Bayesian design that facilitates efficient GO/NoGO decisions relevant to the target population enrolled in each treatment arm. The Bayesian approach estimates the probability that a novel agent is clinically effective and enables decision-making even with small numbers of patients. It can also incorporate prior knowledge, thereby maximising the utility of all available data in this rare population. It facilitates continuous evaluation of any novel agent as the sample size increases.

Furthermore it allows for the discontinuation of an agent if the observed trial data demonstrate a high probability that the novel agent is ineffective at any time, allowing the next agent in the pipeline to be introduced. If the prioritisation of classes of novel agents by the TSC changes, treatment arms can be amended, added, or removed to reflect this. Not all Treatment Arms will necessarily be open to recruitment at all times.

A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma

Occurrence of an objective response (OR) i.e. Complete Response (CR) or Partial Response (PR) after 12 weeks of treatment assessed by Independent Central Review (according to International Paediatric Non-Hodgkin Lymphoma Response Criteria)

Occurrence of CR within a maximum of three cycles of treatment assessed by Independent Central Review (according to International Paediatric Non-Hodgkin Lymphoma Response Criteria)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Participants With Aggressive B-cell Non-Hodgkin Lymphomas	NCT05685173	B-cell Non-Hodg...	Odronextamab REGN5837	18 Years -	Regeneron Pharmaceuticals
Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for Relapsed/Refractory Diffuse Large B-Cell Lymphoma	NCT05338892	Diffuse Large B...	Non-Interventio...	18 Years -	Regeneron Pharmaceuticals
A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With B-cell Non-Hodgkin Lymphoma That Have Been Previously Treated	NCT03888105	B-cell Non-Hodg...	Odronextamab	18 Years -	Regeneron Pharmaceuticals
A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With B-cell Non-Hodgkin Lymphoma That Have Been Previously Treated	NCT03888105	B-cell Non-Hodg...	Odronextamab	18 Years -	Regeneron Pharmaceuticals
A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma	NCT05991388	B-cell Non Hodg...	Odronextamab Loncastuximab t... Rituximab Ifosfamide Carboplatin Etoposide Etoposide Phosp... Dexamethasone CAR T-cells (TB...	- 25 Years	University of Birmingham
A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Participants With Aggressive B-cell Non-Hodgkin Lymphomas	NCT05685173	B-cell Non-Hodg...	Odronextamab REGN5837	18 Years -	Regeneron Pharmaceuticals

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